PBAC's latest decision on Sotorasib: Recommended with restriction (2022). Considered for Treatment of patients with non-squamous or not otherwise specified (NOS) Stage IIIB (locally advanced) or Stage IV (metastatic) non-small cell lung cancer (NSCLC) who harbour the KRAS G12C variant and who have progressed on prior therapy.
PBAC outcome
Recommended with restriction
Authority Required
ICER (AUD/QALY)
Redacted
commercial-in-confidence
Submissions
1
first 2022
Submissions
1
2022 → 2022
Eligible population
Adults with previously treated (progressed on prior therapy) non-squamous or NOS NSCLC with KRAS G12C variant, WHO performance status ≤2, Stage IIIB or Stage IV disease.
Therapy area
Oncology
Line of therapy
Second-line
Evidence base
Single-arm
Primary endpoint
ORR
Pivotal trial size
126 patients
Key trials
CodeBreak 100, CodeBreak 200, SELECT-1
Comparator
docetaxel
Economic model
CUA
ICER note
ICER value is redacted/commercially sensitive — the economic evaluation section is cut off in the provided text.